Applications on novel production methods granted in UK & accepted in Australia

Liverpool, UK – November 7 2016: Videregen Limited, a clinical stage regenerative medicine company developing personalised organ replacements, is pleased to announce progress in the UK and Australia with its intellectual property portfolio on the production of biological scaffolds for organ regeneration and replacement. Patent No GB25060001, which has been granted in the UK, covers the generation of viable implants from intestinal tissue, for use in procedures such as bowel replacements. In Australia, Application No 20142830312 has been accepted, with claims covering production of scaffolds in a range of organ replacements including the trachea which is the company’s lead product.

The organ replacement technology Videregen is developing uses tissue from a cadaveric source, from which the donor cells are stripped (to avoid immune reactions), generating a structurally intact scaffold. The scaffold is then repopulated with a recipient patient’s own cells prior to implantation.

The scaffold generation method described in the Australian patent application, in which donor organs are perfused with decellularisation solution under negative pressure, is particularly effective in dense tissues such as that of the trachea or larynx. The UK patent covers an improved way to produce a tubular section of intestine with a high level of decellularisation and intact vasculature. This is achieved by perfusion through both the blood vessels and the intestinal lumen.

These patents have been assigned to Videregen by Northwick Park Institute for Medical Research, where the techniques were invented. The company has rights to new regenerative medicine technologies from the Institute, and expects its intellectual property portfolio to be further enhanced through its collaborative research efforts. These include the Innovate UK- and Horizon 2020-funded consortia focused on the trachea replacement clinical trial programme. In addition to its patent portfolio, Videregen has significant know-how covering decellularisation and tissue engineering to commercial standard.

Steve Bloor, CEO of Videregen, said, ‘A strong intellectual property portfolio in the major markets worldwide is a prerequisite for the development and commercialisation of our tissue engineered replacement organs for severe medical conditions. These recent developments in our patent estate highlight the innovative nature of our technologies and cement Videregen’s position as a leader in regenerative medicine.’

Videregen is a clinical-stage regenerative medicine company using its proprietary stem cell-based technology platform to develop a range of personalised, non-immunogenic organ replacement products for orphan indications. Its lead programme is a tissue engineered trachea replacement, and its patented technology and know-how is also being applied to the development of other organ replacement products, including mucosal lining, small bowel and liver replacements. The platform technology, which uses decellularised organ scaffolds seeded with the patient’s own cells to create new organs, has the potential to generate cost-effective and curative therapies for a range of devastating diseases. The decellularisation technology was originally developed at Northwick Park Institute for Medical Research. Founded in 2011, Videregen is an SME based in Liverpool. For more information please go to www.videregen.com

About severe structural airway disease and trachea replacement

Severe structural airway disease is associated with significant airway obstruction leading to high levels of morbidity and mortality if not treated successfully. Currently patients are subjected to repeated limited efficacy surgical interventions, such as stent insertions, which ultimately have a high incidence of failure. In contrast, Videregen’s tracheal replacement approach, which involves repopulating an acellular trachea ‘scaffold’ with the patient’s own stem cells, is designed to be a one-off curative treatment without the need for a lifetime of anti-rejection drugs thereafter. The overall incidence of severe structural airway disease is estimated at c.12,000 in EU per year. On average this patient group will spend 22 days in hospital at a cost of €218,619 per patient translating to an EU-wide population cost of €2.6bn per year.

About bowel disease and replacement

Devastating bowel diseases such as Crohn’s disease in adults and necrotising enterocolitis in infants can result in short bowel syndrome (SBS), leading to poor nutrient absorption and increased morbidity and mortality. The primary treatment option is parenteral nutrition (intravenous feeding, bypassing the stomach and bowel), which can be associated with significant side effects with reported 1, 3 and 5 year survival rates of 90%, 70% and 63% respectively. In addition, the EU SBS patient population is believed to cost healthcare providers an estimated €930m pa in parenteral nutrition. Bowel transplants for SBS occur rarely, as a result of a lack of donors and poor outcomes with current techniques. There are thought to be around 13,800 children and neonates in the EU with SBS requiring long-term parenteral nutrition, plus an estimated 9,950 adult SBS patients. Videregen’s replacement bowel product, based on a porcine scaffold, is in preclinical studies.